Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)
1 other identifier
interventional
630
8 countries
101
Brief Summary
"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals. Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone. One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2007
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 28, 2007
CompletedFirst Posted
Study publicly available on registry
August 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 4, 2014
January 1, 2014
1.8 years
August 28, 2007
January 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
June 2009
Secondary Outcomes (6)
Overall Survival
December 2009
Objective response rate
December 2009
Clinical benefit rate
December 2009
Duration of objective response
December 2009
Safety
December 2009
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORElesclomol (STA-4783) in Combination With Paclitaxel
2
OTHERPaclitaxel alone
Interventions
213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops
80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
- ECOG performance status of \<=2
- Measurable disease according to modified RECIST
- Life expectancy of greater than 12 weeks
- LDH \<= 2.0 x ULN
- Clinical lab values within protocol parameters.
- At least 18 years old and able and willing to provide informed consent to participate
You may not qualify if:
- Previous cytotoxic chemotherapy treatment for melanoma
- Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
- Presence of brain metastases
- Presence or history (\<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
- Female subjects who are pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205, United States
University of California San Diego Moores UCSD Cancer Center
La Jolla, California, 92093, United States
University of California, San Diego
La Jolla, California, 92093, United States
The Angeles Clinic & Research Institute
Los Angeles, California, 90025, United States
Jonsson Comprehensive Cancer Center Univ. of California Los Angeles
Los Angeles, California, 90095, United States
Pacific Medical Center Research Institute
San Francisco, California, 94115, United States
Redwood Regional Medical Group
Santa Rosa, California, 94503, United States
Anschutz Cancer Pavillion University of Colorado
Aurora, Colorado, 80010, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Univ. of Miami Hospital and Clinics
Miami, Florida, 33136, United States
MD Anderson Cancer Center
Orlando, Florida, 32806, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Rush University Hospital
Chicago, Illinois, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Joliet Oncology/Hematology Associates, LTD
Joliet, Illinois, 60435, United States
Oncology Specialists, S.C.
Niles, Illinois, 60714, United States
Oncology Specialists, SC
Park Ridge, Illinois, 60068, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute, Wayne State University
Detroit, Michigan, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
Ellis Fischels Cancer Center
Columbia, Missouri, United States
Southeast Nebraska Hematology/Oncology
Lincoln, Nebraska, 68510, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Atlantic Health Research - Mountainside Hospital
Montclair, New Jersey, 07042, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-0001, United States
Monter Cancer Center North Shore Hospital
Lake Success, New York, United States
Weill Medical College of Cornell University - Division of Hematology and Medical Oncology
New York, New York, 10021, United States
NYU Clinical Cancer Center
New York, New York, United States
Stony Brook University Medical Center- Cancer Center
Stony Brook, New York, 11794-9446, United States
UNC School of Medicine - Division of Hematology/Oncology
Chapel Hill, North Carolina, 27599, United States
Carolina Hematology & Oncology Associates
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834, United States
Brody School of Medicine at East Carolina State University
Greenville, North Carolina, 27858, United States
Derrick L. Davis Regional Cancer Center
Winston-Salem, North Carolina, 27103, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
The Ohio State University.
Columbus, Ohio, 43210, United States
Mark H. Zangmeister Cancer Center
Columbus, Ohio, 43219, United States
Providence Cancer Center Clinical Trials
Portland, Oregon, 97213, United States
St. Luke's Cancer Center
Bethlehem, Pennsylvania, 18015, United States
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Cancer Pavilion
Pittsburgh, Pennsylvania, 15323, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Vanderbilt Medical Center
Nashville, Tennessee, 27232-6868, United States
Texas Oncology, PA
Dallas, Texas, 75246, United States
San Antonio Cancer Institute
San Antonio, Texas, 78229, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Lismore Base Hospital, Cancer Care & Haematology Unit
Lismore, New South Wales, Australia
Newcastle Melanoma Unit - Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500, Australia
Redcliffe Hospital
Redcliffe, Queensland, 4020, Australia
Princess Alexandra Hospital
Wooloongabba, Queensland, 4102, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Royal Adelaide Cancer Centre Medical Oncology
Adelaide, SA 5000, Australia
Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital
North Sydney, Australia
The Tweed Hospital
Tweed Heads, Australia
Department of Medical Oncology, Westmead Hospital
Westmead, Australia
Tom Baker Cancer Centre
Calgary, Alberta, Canada
QE II Health Sciences Center
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, Canada
Cross Cancer Institute
Edmonton, AB T6G 1Z2, Canada
Princess Margaret Hospital
Toronto, Canada
Vivantes Klinikum Im Friedrichshain
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Elbe-Klinikum Buxtehude
Buxtehude, Germany
Universität zu Köln
Cologne, Germany
University Frankfurt
Frankfurt am Main, Germany
University of Kiel
Kiel, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Universitätsklinikum Münster
Münster, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
VA Medical Center
San Juan, 00927, Puerto Rico
County Hospital Brasov - Oncology Department
Brasov, 500 117, Romania
Oncology Institute "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, 400 015, Romania
Clinical County Hospital " Alexandru Simionescu" Hunedoara
Hunedoara, 331 057, Romania
Center of Medical Oncology
Iași, 700 106, Romania
Clinical County Hospital Sibiu
Sibiu, 550 245, Romania
Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital
Timișoara, 300 223, Romania
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Universitario de la Princessa Servicio de Oncología Médica
Madrid, 28006, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos
Toledo, Spain
Oncology Centre Addenbrookes's Hospital
Cambridge, CB2 0QQ, United Kingdom
Northern Centre for Cancer Treatment Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE, United Kingdom
Dorset Cancer Centre Poole Hospital NHS Foundation Trust
Poole, BH15 2JB, United Kingdom
Related Publications (1)
O'Day SJ, Eggermont AM, Chiarion-Sileni V, Kefford R, Grob JJ, Mortier L, Robert C, Schachter J, Testori A, Mackiewicz J, Friedlander P, Garbe C, Ugurel S, Collichio F, Guo W, Lufkin J, Bahcall S, Vukovic V, Hauschild A. Final results of phase III SYMMETRY study: randomized, double-blind trial of elesclomol plus paclitaxel versus paclitaxel alone as treatment for chemotherapy-naive patients with advanced melanoma. J Clin Oncol. 2013 Mar 20;31(9):1211-8. doi: 10.1200/JCO.2012.44.5585. Epub 2013 Feb 11.
PMID: 23401447DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2007
First Posted
August 30, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 4, 2014
Record last verified: 2014-01